TY - JOUR
T1 - Incidence of hypersensitivity and anaphylaxis with sugammadex
AU - Min, K. Chris
AU - Woo, Tiffany
AU - Assaid, Christopher
AU - McCrea, Jacqueline
AU - Gurner, Deborah M.
AU - Sisk, Christine Mc Crary
AU - Adkinson, Franklin
AU - Herring, W. Joseph
N1 - Funding Information:
Funding for the study was provided by Merck & Co., Inc., Kenilworth, NJ, USA.
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/6
Y1 - 2018/6
N2 - Study objective: To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex. Design: Retrospective analysis. Setting: Sugammadex clinical development program and post-marketing experience. Patients: Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB). Interventions: Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1–2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg. Measurements: Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1. Main results: The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity (<1%), with no differences between sugammadex and placebo or neostigmine. Finally, the retrospective adjudication of AEs suggestive of hypersensitivity showed a low incidence of hypersensitivity (0.56% and 0.21% for sugammadex 2 mg/kg and 4 mg/kg, respectively), with an incidence similar to subjects who received placebo (0.55%). There were no confirmed cases of anaphylaxis in the pooled studies. During post-marketing use, spontaneous reports of anaphylaxis occurred with approximately 0.01% of sugammadex doses. Conclusions: Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine.
AB - Study objective: To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex. Design: Retrospective analysis. Setting: Sugammadex clinical development program and post-marketing experience. Patients: Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB). Interventions: Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1–2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg. Measurements: Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1. Main results: The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity (<1%), with no differences between sugammadex and placebo or neostigmine. Finally, the retrospective adjudication of AEs suggestive of hypersensitivity showed a low incidence of hypersensitivity (0.56% and 0.21% for sugammadex 2 mg/kg and 4 mg/kg, respectively), with an incidence similar to subjects who received placebo (0.55%). There were no confirmed cases of anaphylaxis in the pooled studies. During post-marketing use, spontaneous reports of anaphylaxis occurred with approximately 0.01% of sugammadex doses. Conclusions: Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine.
KW - Anaphylaxis
KW - Hypersensitivity
KW - Sugammadex
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U2 - 10.1016/j.jclinane.2018.03.018
DO - 10.1016/j.jclinane.2018.03.018
M3 - Article
C2 - 29621739
AN - SCOPUS:85056228800
SN - 0952-8180
VL - 47
SP - 67
EP - 73
JO - Journal of Clinical Anesthesia
JF - Journal of Clinical Anesthesia
ER -